Daratumumab is a CD38 monoclonal antibody, which has been approved for the treatment of newly-diagnosed multiple myeloma and has shown promising activity in pre-clinical NHL models. The aim of this global, proof-of-concept, phase II trial (NCT02413489) was to investigate whether single-agent daratumumab is efficient and safe for R/R mantle cell lymphoma (MCL), diffuse large B-cell lymphoma (DLBCL), and follicular lymphoma (FL) patients. The primary endpoint of the trial was overall response rate (ORR). Secondary endpoints, included safety and pharmacokinetics.

Study design & baseline characteristics

N = 36 R/R NHL patients:

DLBCL: n = 15 patients

FL: n = 16 patients

MCL: n = 5 patients

Median patient age (range): 64 (43–82) years

Median time since diagnosis: 37.9 months

Median number of prior treatment lines across all patients (range): 3 (2–10)

All FL patients were previously-treated with rituximab and all MCL patients with ibrutinib

Overall median CD38 expression across enrolled patients: 70%

DLBCL: 80%

FL: 67.5%

MCL: 60%

Dosing:

Daratumumab (28-day cycles): 16 mg/kg by intravenous (IV) infusion once every week for eight weeks; then, every other week for 16 weeks; thereafter, every four weeks until disease progression (PD), unacceptable toxicity or study end

Pre-infusion medications:

Methylprednisolone: 100 mg IV, one hour prior to daratumumab for the first two infusions and 60 mg IV thereafter

Oral methylprednisolone of 20 mg was administered two days after the first three daratumumab infusions

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